The strong endorsement from an FDA advisory committee yesterday of gout drug, Krystexxa, would have come as a big relief to Savient Pharmaceuticals and its investors, who saw shares in the company plunge last year on the back of safety concerns.
The 14 to 1 vote in favour of approval sent the stock back towards pre-scare levels, and in early morning trade it had touched $12.38, up an impressive 34%. The stock sunk as low as $3.07 last November, on fears that cardiovascular safety signals would de-rail the project. Still, a green light from the FDA by the August 1 PDUFA date is still far from guaranteed, and at the very least a patient monitoring programme will probably be required.
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